ASTM F619-14
(Practice)Standard Practice for Extraction of Medical Plastics
Standard Practice for Extraction of Medical Plastics
SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices.
5.2 The limitations of the results obtained from this practice should be recognized. The choice of extraction vehicle, duration of immersion, and temperature of the test is necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics to extraction vehicles.
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 4).
5.4 Caution should be exercised in the understanding and intent of this practice as follows:
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, or absorptive, or resorptive, should be considered with caution. Consideration should be given to altering the specified material to liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test article. Additional procedures that fully remove the extract liquid from the test article, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and plastic specimen physical structure should be taken into account.
5.5 Test Methods D543, D570, and D1239 may be useful in providing supplemental information.
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.3 1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F619 − 14
Standard Practice for
1
Extraction of Medical Plastics
ThisstandardisissuedunderthefixeddesignationF619;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D543 Practices for Evaluating the Resistance of Plastics to
Chemical Reagents
1.1 This practice covers methods of extraction of medical
D570 Test Method for Water Absorption of Plastics
plastics and may be applicable to other materials. This practice
D1193 Specification for Reagent Water
identifies a method for obtaining “extract liquid” for use in
D1239 Test Method for Resistance of Plastic Films to
determining the biological response in preclinical testing.
Extraction by Chemicals
Further testing of the “extract liquid” is specified in other
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D1898 Practice for Sampling of Plastics (Withdrawn 1998)
ASTM standards. The extract may undergo chemical analysis
F748 PracticeforSelectingGenericBiologicalTestMethods
as part of the preclinical evaluation of the biological response,
for Materials and Devices
and the material after extraction may also be examined.
2.2 Other Documents:
1.2 This practice may be used for, but is not limited to the
4
USP NF 24 or current edition
following areas: partial evaluation of raw materials, auditing
materials within the manufacturing process, and testing final
3. Definitions
products. This practice may also be used as a referee method
3.1 extraction vehicle—a liquid specified for use in testing
for the measurement of extractables in plastics used in medical
the plastic. Specific extraction vehicles are to be designated by
devices.
theASTM standard that references this practice (see Section 7
1.3 This practice was initially developed for extraction of
for a list of standard extraction vehicles).
medical plastics not intended to undergo degradation or ab-
3.2 extract liquid—that liquid which, after extraction of the
sorption during normal medical device usage. When applied to
specimen, is used in tests.
the extraction of absorbable materials, additional consider-
ations may be necessary in the selection of extraction proce- 3.3 specimen portion—theunitorunitsofplasticplacedinto
the extraction vehicle.
dures and fluids.
3.4 blank—the extraction vehicle not containing the speci-
1.4 The values stated in inch-pound units are to be regarded
as standard. The values given in parentheses are mathematical men under test which is used for comparison with the extract
liquid.
conversions to SI units that are provided for information only
and are not considered standard.
4. Summary of Practice
1.5 This standard does not purport to address all of the
4.1 Standard-size specimens of the plastic, which may
safety concerns, if any, associated with its use. It is the
closely simulate the intended device depending upon the use,
responsibility of the user of this standard to establish appro-
areimmersedindefinedvolumesofselectedliquids(extraction
priate safety and health practices and determine the applica-
vehicles) for the time and temperature specified.
bility of regulatory limitations prior to use.
4.2 Achoiceismade,basedontheenduse,oftheextraction
2. Referenced Documents
vehicles (see Section 7) and one of the combinations of time
2
2.1 ASTM Standards:
and temperature for the test (see Section 12).
4.3 The resultant test liquids (extract liquids) are kept in
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ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland suitable containers as described in 6.3 until used for testing.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
The test liquids shall be stored tightly stoppered at normal
F04.16 on Biocompatibility Test Methods.
room temperature.Test liquids for biological testing are kept in
Current edition approved March 1, 2014. Published April 2014. Originally
approved in 1979. Last previous edition approved in 2008 as F619 – 03 (2008).
DOI: 10.1520/F0619-14.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F619 − 14
sterile containers. Consideration should be given as to whether 6.2.1 Ovensorincubatorsthatwillmaintaintemperatureso
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F619 − 03 (Reapproved 2008) F619 − 14
Standard Practice for
1
Extraction of Medical Plastics
This standard is issued under the fixed designation F619; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice
identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further
testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the
preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials
within the manufacturing process, and testing final products. This practice may also be used as a referee method for the
measurement of extractables in plastics used in medical devices.
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption
during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be
necessary in the selection of extraction procedures and fluids.
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D570 Test Method for Water Absorption of Plastics
D1193 Specification for Reagent Water
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2 Other Documents:
4
USP NF 24 or current edition
3. Definitions
3.1 extraction vehicle—a liquid specified for use in testing the plastic. Specific extraction vehicles are to be designated by the
ASTM standard that references this practice (see Section 7 for a list of standard extraction vehicles).
3.2 extract liquid—that liquid which, after extraction of the specimen, is used in tests.
3.3 specimen portion—the unit or units of plastic placed into the extraction vehicle.
3.4 blank—the extraction vehicle not containing the specimen under test which is used for comparison with the extract liquid.
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This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Aug. 1, 2008March 1, 2014. Published August 2008April 2014. Originally approved in 1979. Last previous edition approved in 20032008 as
F619 – 03.F619 – 03 (2008). DOI: 10.1520/F0619-03R08.10.1520/F0619-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F619 − 14
4. Summary of Practice
4.1 Standard-size specimens of the plastic, which may closely simulate the intended device depending upon the use, are
immersed in defined volumes of selected liquids (extraction vehicles) for the time and temperature specified.
4.2 A choice is made, based on the end use, of the extraction vehicles (see Section 7) and one of the combinations
...
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